DIN EN ISO 16054-2002 外科植入物.外科植入物的最小数据集 (ISO 16054:2000); 德文版本 EN ISO 16054:2002

标准号：DIN EN ISO 16054-2002
中文标准名称：外科植入物.外科植入物的*小数据集 (ISO 16054:2000); 德文版本 EN ISO 16054:2002
英文标准名称：Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000); German version EN ISO 16054:2002
标准类型：C35
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C35
国际标准分类号：11.040.40
适用范围：This international standard defines minimum data sets to facilitate recording and international exchange of data for the purposes of registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of implant tracking to allow recall for product correction or patient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data requirements to allow cross referencing between extended data sets for the purposes of retrieval analysis and research.